1. Field of the Invention
The present invention relates to a combined umbilical cord clamp, cutter, disinfectant, and data collecting system which reduces the risk of cord infections due to unsanitary birth conditions and also provides an identification system which aids in the collection of birth statistics.
2. Description of Related Art
Infections represent one of the most common complications of childbirth. Even in developed countries, individual cases and epidemics of cord infections continue to occur. In developing nations where health care infrastructure is commonly limited and inadequate, most deliveries occur outside a hospital setting with help from family or traditional birth attendants. Two-thirds of neonatal deaths worldwide occur in Africa and Southeast Asia, where traditional birth practices involve severing the cord using non-sterile instruments that often lead to infection. This is due not only to poor access to quality care but also socio-cultural behaviors. In many cultures, some type of ritual substance is applied to the cord stump. Ash, oil, butter, spice pastes, herbs, mud, and cow or chicken dung are commonly used, and they are often contaminated with bacteria and spores. This practice of applying substances to the cord is most commonly employed to prevent bleeding, to promote separation of the stump, and to keep spirits away. With such unsanitary conditions, there exists a much higher rate of infant mortality due to preventable causes, such as bacterial infections and neonatal tetanus. The lack of research efforts targeted at birth conditions outside of hospitals in developing nations has simultaneously prevented the development of effective, affordable, and feasible preventative strategies that could be widely applied towards neonatal health.
The first few weeks of a newborn mammal's life are critical to its long-term survival and health. Umbilical cord care is just as important in veterinary use as it is in human use, especially since the environment an animal is born into is usually less sterile than that of a human birth. The umbilical cord is usually severed immediately after a birth, and typically a disinfectant is applied to prevent pathogens from entering an animal's body through the cord. Umbilical cord devices are rarely used in veterinary medicine, even though they could be equally as beneficial in helping to prevent infection. Large animal births, in particular, could benefit from an improved means of severing, disinfecting, and covering the umbilical cord, as many large animal births are not attended by a trained veterinarian but by a livestock handler.
An additional difficulty in improving neonatal health is the lack of accurate, reliable and up-to-date data. When data is available, its usefulness is often questioned, with concerns related to limited coverage and poor quality of collection. Often times, birth estimates are extrapolated from data collected outside of the areas and settings of interest. A need exists for a disposable, sterile, and comprehensive clamping and cutting device for the severing of the umbilical cord that would also aid in collecting data on birth rates through the use of an automatic identification method. Currently, identification methods such as radio-frequency identification (RFID) tags are gaining popularity in many hospitals, whereby wrist or ankle bracelets are placed on the mother and infant. However, integration of an identification method into a medical device eliminates the extra step of placing a tag on the newborn during the chaotic period after a birth, and it could prevent a mother/baby mix-up in the hospital setting when a baby is sent to the wrong mother after being separated for neonatal care. This could also apply to domesticated mammals by providing an identification method early in the animal's life before a more permanent form of identification is implemented.
Currently, there is limited support for research that focuses on the preventable causes of neonatal infection and death. A key disadvantage of the present umbilical cord cutting method is its multi-step nature; the procedure of severing the umbilical cord involves three pieces of equipment: two clamps and a cutter. In practice, two metal clamps are secured to the umbilical cord in a spaced relation to one another, and the cord is then cut between the two clamps using scissors. The metal clamp on the baby's side is then replaced with a plastic clamp and the other is removed when the placenta is discarded. Outside of the hospital, the method for severing the umbilical cord often involves the use of tying devices, usually a type of string, to stop the flow of blood and a sharp blade, often contaminated, to sever the cord between the two points. Additionally, cutting the cord at an intermediate distance between two clamps leaves an edge of the cord past the clamp, which is a prime site for infection.
Various surgical instruments have been developed to separate and clamp the umbilical cord joining a newborn infant and the mother. However, most are reusable, which presents additional health concerns due to the possibility of contamination and infection; those that claim not to be reusable still utilize a metallic cutting device that could be easily removed and reused. The metallic blade is problematic for three reasons: it is a safety hazard, there is a risk of the blade being removed for reuse, and it is less economical to manufacture. In addition, variations on obstetric scissors do not provide adequate protection from blood splatter, placing the birth attendant at risk from contracting Hepatitis B, Hepatitis C, and Human Immunovirus. Furthermore, it is usually necessary to first orient the device so that the clamp side with the blade remains on the mother's side of the cord to be discarded with the placenta. Improper orientation of such devices is more likely to occur in developing nations because language barriers and low levels of literacy will limit the effectiveness of providing instructions for proper use. This type of mistake may leave the wrong side of the device with the newborn, possibly resulting in infection and various other complications.
An initial application of antimicrobials onto the stump of the umbilical cord can contribute to protection against neonatal tetanus, especially in the first three days of life where the stump of the umbilical cord may be exposed to environmental contaminants. In addition, application of antimicrobials onto the umbilical stump can reduce the risk of sepsis, which is a major cause of infant death in developing countries. Prevention of neonatal tetanus and other infections remains a challenge in spite of the availability of vaccines and agency efforts to train birth attendants in cord-care practices. Topical antimicrobials applied to the stump of the umbilical cord can provide additional benefits to a vaccine program or to a situation where such a program is not well established. Topical agents are easy to distribute and use; however, when an antimicrobial is applied by the traditional birth attendant or the mother, it may not be applied appropriately in a sterile environment. Therefore, a device which incorporates an antimicrobial into the design would be very beneficial. Further, plastic materials used in the medical field can easily be colonized by microorganisms, whether the birth occurs inside or outside of a hospital. In areas with a high incidence of neonatal tetanus and sepsis, an umbilical cutting device that incorporates an antimicrobial plastic could reduce the risk of infections of the umbilical stump.
The present invention provides an efficient and user-friendly device to simultaneously clamp, cut, and disinfect the umbilical cord and also to provide a method of data collection and identification. The design of this device focuses on ease of use, whereby an unskilled person can safely and effectively cut an umbilical cord. To decrease manufacturing costs, each device will be made entirely of plastic, including the cutting mechanism. A symmetrical design allows the orientation of the device to be irrelevant during use, which further decreases its complexity. That is, the side of the device that the birth attendant faces towards the infant is irrelevant. Each device will either contain a disinfectant packet that will be severed simultaneously with the umbilical cord, or the device will be made of an antimicrobial plastic to provide a sterilized environment for the cord. Each clamp/cutter piece slides apart along the axis of the cord, and one of the clamp/cutters remains with the infant. Thus, the detached clamp protects and eliminates access to the umbilical stump wound, containing the cut umbilical cord until it atrophies and falls off. A minimum of one locking mechanism is incorporated to ensure that the device cannot be reopened.
Further embodiments of this invention provide a birth identification method for developing nations through the use of passive RFID tags embedded in each clamping/cutting constituent. After a birth and the use of the device to sever the umbilical cord of a newborn, the detached clamping/cutting constituent not remaining with the infant can be taken to a collection center. As an incentive, the separated component acts as a token, and could be exchanged for essential supplies such as baby formula, food, or necessary vaccinations. With the collected device containing the RFID tag, a computer can collect data on the number of births in a particular area.
Another embodiment of this invention provides a birth identification method for developed nations and veterinary applications through the use of RFID tags embedded in each clamping/cutting constituent. Any mother/baby or owner/animal mix-up is a potential liability to a hospital; therefore, an RFID system can increase safety and ensure security of a newborn. After a birth, the device can be used to track the newborn effectively linking the mother to the child, which will help in cases of child theft or hospital mix-ups. This technology could also provide valuable birth statistics.
While certain novel features of this invention shown and described below are pointed out in the annexed claims, the invention is not intended to be limited to the details specified, since a person of ordinary skill in the relevant art will understand that various omissions, modifications, substitutions and changes in the forms and details of the device illustrated and in its operation may be made without departing in any way from the spirit of the present invention. No feature of the invention is critical or essential unless it is expressly stated as being “critical” or “essential.”